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Directed Systems’ Hypotension Decision Assist software supports anesthesiologists by providing intuitive visualization on a single display of at-a-glance, time-critical information about emerging critical cardiovascular situations in the operating room. Read More
Qiagen’s QuantiFERON assay can detect CD4+ and CD8+ T-cell responses, which allows a comprehensive assessment of the immunity produced by the COVID-19 vaccine. Read More
Becton Dickinson (BD) is spinning off its diabetes care business under the name “embecta,” the Franklin Lakes, N.J.-based device giant announced yesterday. Read More
Louisville, Ky.-based devicemaker Induction Therapies has been marketing a microneedling product without FDA approval, the agency said in a warning letter to the company. Read More
Device manufacturing facility workers are routinely exposed to biohazards when they reprocess devices for reuse, even when they are wearing personal protective equipment, researchers have found. Read More
Device industry groups are hesitant to fully endorse the FDA’s push for greater transparency by manufacturers in the labeling information they provide to users of their artificial intelligence- or machine learning-enabled devices. Read More
“Quality issues are common events in the lifecycle of medical devices, especially during the production ramp-up phase,” said the company’s CEO. Read More